Amblyopia
Conditions
Brief summary
Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works in about 70% of children, but parents and children strongly dislike these treatments which may carry on for years and involve frequent clinic visits. In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console with movies, or standard patching/blurring eye-drop treatment. The Investigators will monitor adverse events (double vision), change in the balance between the two eyes and in visual acuity over 16 weeks.
Detailed description
Lazy eye (amblyopia) is the commonest sight problem in children, affecting about one in 30 children. It is caused by a difference in spectacle prescription between the eyes and/or a squint (eye misalignment), with the brain ignoring one eye. Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works in about 70% of children, but parents and children strongly dislike these treatments which may carry on for years and involve frequent clinic visits. The Investigators have developed an exciting new treatment: children watch customized movies for an hour a day on a hand-held 3D computer-game console. The Investigators blur the picture that the good eye sees to match it with what the weaker eye sees. They have tested this approach on 22 children, with an average improvement in vision by three lines on the test chart over 8 - 24 weeks, which may be faster than with standard treatment. Parents and children the Investigators have spoken with like both the idea of research in this area and the engaging nature of this device. The Investigators now need to assess how the new treatment compares with standard treatment, but first need to ensure that the new treatment is safe and that families will use it. In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console with movies, or standard patching/blurring eye-drop treatment. The Investigators will monitor adverse events (double vision), change in the balance between the two eyes and in visual acuity over 16 weeks. Parents and children have helped develop this pilot - this involvement will be continued throughout the study. At study completion, children and parents will be involved in deciding how best to communicate the findings on hospital websites, in newsletters, at conferences and in medical journals.
Interventions
DEVICEBalanced Binocular Viewing (BBV)
The dose of BBV therapy will be one hour a day or 2x30 min/day (depending on child's attention span and/or need to implement the treatment around the family daily routine).
OTHERStandard Therapy - Occlusion (patching) or blurring (atropine)
The prescribed dose of occlusion treatment / patching (parental choice) will depend on the severity of amblyopia, as by current clinical practice based on PEDIG studies
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
At each site, a masked orthoptist will carry out the study assessments.
Intervention model description
Two-group parallel randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Age between 3.0 and less than 8.0 years * unilateral anisometropic, strabismic or combined mechanism amblyopia * best-corrected crowded logMAR visual acuity (BCVA) in the amblyopic eye worse than 0.2logMar * best corrected visual acuity in the better seeing eye 0.2 or better * difference in best corrected visual acuity between the two eyes of 0.2 logMAR or more * adapted to spectacles with no improvement in acuity in affected eye for two consecutive visits * no previous treatment for amblyopia other than glasses
Exclusion criteria
* ocular cause for reduced visual acuity * inability to co-operate with assessment tests * other developmental disorders or learning or neurological disability that would impact on adherence to treatment * photopic epilepsy * myopia with spherical equivalent of greater than -6.00DS * previous intraocular surgery * inability to perform a crowded letter logMAR visual acuity test using a clinical trials standard testing method (ATS-HOTV protocol), either by naming or by matching letters
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The evaluation of safety of the experimental intervention | 16 weeks from randomization | To measure changes in suppression/interocular balance (considered to precede double vision) at 16 weeks from baseline, using a novel test of interocular balance, a contrast-sensitivity test presented on a PC |
Countries
United Kingdom
Outcome results
None listed